Filed on behalf of: Gold Standard Instruments, LLC
`
`By:
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`Paper No. ____
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`Joseph A. Hynds, Lead Counsel
`R. Elizabeth Brenner-Leifer, Back-up Counsel
`Steven Lieberman, Pro Hac Vice
`Derek F. Dahlgren, Pro Hac Vice
`Jason M. Nolan, Back-up Counsel
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040
`Facsimile: 202-783-6031
`Emails: jhynds@rothwellfigg.com
` ebrenner@rothwellfigg.com
` slieberman@rothwellfigg.com
` ddahlgren@rothwellfigg.com
` jnolan@rothwellfigg.com
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`US ENDODONTICS, LLC,
`Petitioner,
`
`v.
`
`GOLD STANDARD INSTRUMENTS, LLC,
`Patent Owner.
`_______________
`
`Case IPR2015-00632
`Patent 8,727,773 B2
`_______________
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES ..................................................................................... v 
`TABLE OF ABBREVIATIONS ............................................................................ vii 
`EXHIBIT LIST ........................................................................................................ ix 
`I. 
`INTRODUCTION ........................................................................................... 1 
`II. 
`THE ’773 PATENT ......................................................................................... 3 
`A.  General Background of the ’773 Patent ................................................ 3 
`1. 
`How Endodontic Files are Used ................................................. 3 
`2. 
`Dr. Luebke’s Invention ............................................................... 6 
`The Claims of the ʼ773 Patent ............................................................... 8 
`B. 
`The field of invention and the person of ordinary skill in the art. ........ 9 
`C. 
`III.  CLAIM CONSTRUCTION .......................................................................... 10 
`A. 
`The Board correctly determined that the limitation requiring that
`the heat-treated instrument exhibit at least 10 degrees of
`permanent deformation after the ISO Standard 3630-1 bend test
`should not be read out of the claims. ................................................... 10 
`The Board correctly construed the claims as atmosphere-neutral. ..... 14 
`B. 
`IV.  KUHN DOES NOT ANTICIPATE CLAIMS 1, 2 OR 9-12. ....................... 15 
`A.  Kuhn does not teach or suggest making a permanently
`deformable file and does not show the specific level of
`deformation required by the claims. .................................................... 15 
`Kuhn nowhere teaches or suggests heat-treating the entire shank. ..... 17 
`None of Kuhn’s heat-treated shank pieces demonstrate at least 10
`degrees of permanent deformation in the ISO test. ............................. 20 
`1. 
`Kuhn does not identify the bend test used. ............................... 20 
`2. 
`Kuhn also explicitly states that the heat-treated shank
`pieces recovered their original shape. ....................................... 22 
`The Figure 6A bending curves show heat-treated shanks
`that maintained their superelasticity. ........................................ 24 
`
`B. 
`C. 
`
`3. 
`
`ii
`
`

`
`V. 
`
`Kuhn’s 2001 companion article—which Dr. Goldberg
`admits he never reviewed—confirms that the heat-treated
`shanks discussed in Kuhn are superelastic. .............................. 27 
`The Fig. 4A DSC thermograms do not show that the heat-
`treated shanks would have at least 10 degrees of
`permanent deformation in the ISO test. .................................... 28 
`Kuhn affirmatively teaches that superelasticity of NiTi
`files is a good thing and thus expressly teaches away from
`the claimed invention. ............................................................... 33 
`CLAIMS 8, 13, 15 AND 17 ARE NOT PRIMA FACIE OBVIOUS
`OVER KUHN AND THE 1992 ISO. ............................................................ 34 
`A. 
`The 1992 ISO describes the recited bend test but nowhere
`discusses NiTi files or heat-treatments. .............................................. 34 
`The 1992 ISO does not bridge gaps between Kuhn and the
`claims. .................................................................................................. 35 
`VI.  CLAIMS 1-17 ARE NOT PRIMA FACIE OBVIOUS OVER KUHN,
`THE 1992 ISO, MCSPADDEN, AND PELTON ......................................... 36 
`A.  McSpadden seeks to make a stiffer NiTi file, not a permanently
`deformable file. ................................................................................... 37 
`Pelton seeks to optimize superelasticity and nowhere teaches or
`suggests making a permanently deformable file. ................................ 42 
`The Cited References Do Not Teach or Suggest the Particular
`Time and Temperature Combinations of the ’773 Patent ................... 42 
`D.  McSpadden, Pelton, and the 1992 ISO do not bridge the critical
`gaps between Kuhn and the claimed invention. .................................. 43 
`VII.  CLAIMS 1-17 ARE NOT PRIMA FACIE OBVIOUS OVER
`MATSUTANI, PELTON AND THE 1992 ISO ........................................... 47 
`A.  Matsutani is interested in making a NiTi endodontic file that is
`superelastic everywhere except for the very tip, and he
`discourages heat-treating the entire file shank. ................................... 47 
`Pelton and the 1992 ISO cannot compensate for the fact that
`Matsutani’s file is superelastic everywhere except for the tip. ........... 52 
`The Combination of Matsutani, Pelton, and the 1992 ISO Does
`Not Result in Permanent Deformation as Required ............................ 52 
`
`B. 
`
`B. 
`
`C. 
`
`B. 
`
`C. 
`
`4. 
`
`5. 
`
`6. 
`
`iii
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`

`
`B. 
`
`VIII.  OBJECTIVE EVIDENCE CONFIRMS THE NOVELTY AND NON-
`OBVIOUSNESS OF THE CLAIMED INVENTION .................................. 54 
`A.  Dr. Luebke’s invention met a long-felt need for an endodontic
`file that navigates the canal better and fractures less—problems
`others failed to solve............................................................................ 56 
`Skepticism by Experts confirms the patentability of the
`invention. ............................................................................................. 58 
`The invention has enjoyed commercial success.................................. 58 
`C. 
`The invention has been copied by others, including Petitioner. ......... 58 
`D. 
`Praise by others ................................................................................... 59 
`E. 
`IX.  CONCLUSION .............................................................................................. 60 
`
`
`iv
`
`

`
`TABLE OF AUTHORITIES
`
`Cases 
`
`Apple Inc. v. ITC,
`725 F.3d 1356 (Fed. Cir. 2013) ............................................................................ 54
`
`Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc.,
`567 F.3d 1314 (Fed. Cir. 2009) ............................................................................ 42
`
`Ecolochem, Inc. v. S. Cal. Edison Co.,
`227 F.3d 1361 (Fed. Cir. 2000) ............................................................................ 55
`
`In re Cuozzo Speed Techs., LLC.,
`778 F.3d 1271 (Fed. Cir. 2015) ............................................................................ 15
`
`In re Gurley,
`27 F.3d 551 (Fed. Cir. 1994) ................................................................................ 48
`
`In re Rosenberger,
`386 F.2d 1015 (C.C.P.A. 1967) ........................................................................... 40
`
`InTouch Techs., Inc. v. VGo Commc’ns., Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) ............................................................................ 49
`
`Leo Pharm. Prods. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ............................................................................ 54
`
`Plantronics, Inc. v. Aliph, Inc.,
`724 F.3d 1343 (Fed. Cir. 2013) ............................................................................ 54
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................ 54
`
`W.L. Gore & Assocs., Inc. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) ............................................................................ 49
`
`Statutes 
`
`35 U.S.C. § 102(b) ..................................................................................................... 1
`
`35 U.S.C. § 103(a) ..................................................................................................... 1
`
`v
`
`

`
`Rules 
`
`37 C.F.R. § 42.100(b) .............................................................................................. 15
`
`37 C.F.R. § 42.120(a) ................................................................................................. 1
`
`Regulations 
`Patent Trial Practice Guide,
`77 Fed. Reg. 48756 (Aug. 14, 2012) ............................................................. 15, 34
`
`
`
`
`
`
`
`vi
`
`

`
`GSI
`Petitioner
`Edge Endo
`Pet.
`POPR
`POR
`Board
`PTO
`IPR
`Paper 29
`
`Paper 37
`
`
`ʼ773 patent
`ISO
`1992 ISO
`2008 ISO
`Kuhn
`Kuhn 2001
`Matsutani
`Matsutani 2006
`McSpadden
`Pelton
`
`Af
`As
`Ms
`
`TABLE OF ABBREVIATIONS
`
`Gold Standard Instruments, LLC
`US Endodontics, LLC
`Edge Endo, LLC
`Petition for Inter Partes Review
`Patent Owner Preliminary Response
`Patent Owner Response
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`Inter Partes Review
`US Endodontics, LLC v. Gold Standard Instruments, LLC,
`IPR2015-00632, Institution of Inter Partes Review (Aug. 5,
`2015).
`US Endodontics, LLC v. Gold Standard Instruments, LLC,
`IPR2015-00632, Petitioner’s Motion to Submit Supplemental
`Information Pursuant to 37 C.F.R. § 42.123(a) (Aug. 28, 2015).
`U.S. Patent 8,727,773 (Ex. 1001)
`International Organization for Standardization
`International Standard ISO3630-1 (1st ed. 1992) (Ex. 1016)
`International Standard ISO3630-1 (2d ed. 2008) (Ex. 1017)
`Kuhn et al., 28 J. Endodontics 716 (2002) (Ex. 1019)
`Kuhn et al., 27 J. Endodontics 516 (2001) (Ex. 2024)
`U.S. Patent 7,713,815 B2 (Ex. 1023)
`Japanese Patent App. Pub. No. 2006-149675 (Ex. 1026)
`U.S. Patent App. Pub. No. 2002/0137008 A1 (Ex. 1022)
`Pelton et al., 9 Minimally Invasive Therapies and Allied Techs.
`107 (2000) (Ex. 1006)
`Austenite finish temperature
`Austenite start temperature
`Martensite start temperature
`
`vii
`
`

`
`Mf
`Rs
`Rf
`NiTi
`DSC
`SEM
`XRD
`§ 102
`§ 103
`Rule 42.120(a)
`Rule 42.100(b)
`
`Martensite finish temperature
`R-phase start temperature
`R-phase finish temperature
`Nickel titanium
`Differential scanning calorimetry
`Scanning electron microscopy
`X-ray diffraction
`35 U.S.C. § 102
`35 U.S.C. § 103
`37 C.F.R. § 42.120(a)
`37 C.F.R. § 42.100(b)
`
`
`
`
`viii
`
`

`
`Exhibits Previously Submitted
`
`EXHIBIT LIST
`
`Ex. 1004
`
`Ex. 1005
`
`Petitioner’s Prior Exhibits
`
`Ex. 1001 U.S. Patent No. 8,727,773 (the “’773 Patent”)
`Ex. 1002 Declaration of Jon Goldberg, Ph.D.
`Ex. 1003 Harmeet Walia et al., An Initial Investigation of the Bending and
`Torsional Properties of Nitinol Root Canal Files, 14 J.
`ENDODONTICS 346 (1988) (“Walia”)
`Fujio Miura et al., The super-elastic property of the Japanese NiTi
`alloy wire for use in orthodontics, 90 AM. J. ORTHODONTICS &
`DENTOFACIAL ORTHOPEDICS 1 (1986) (“Miura”)
`Satish B. Alapati, “An investigation of phase transformation
`mechanisms for nickel-titanium rotary endodontic instruments,” PhD
`thesis, 2006 (“Alapati”)
`Ex. 1006 Alan R. Pelton et al., Optimisation of Processing and Properties of
`Medical-Grade Nitinol Wire, 9 Minimally Invasive Therapies
`& Allied Techs. 107 (2000) (“Pelton”)
`Ex. 1007 U.S. Patent No. 5,697,906 to Ariola et al.
`Ex. 1008
`Prosecution history of the ‘773 patent
`Ex. 1009
`Prosecution history of U.S. Patent No. 8,062,033
`Ex. 1010
`Prosecution history of U.S. Patent no. 8,562,341
`Ex. 1011 US. Provisional Patent Application No. 60/578,091
`Ex. 1012 U.S. Patent Application Publication No. 2008/0032260 A1, Luebke
`Ex. 1013
`Prosecution history of U.S. Patent No. 8,083,873
`Ex. 1014 U.S. Patent Application Publication No. 2011/0271529 A1, Gao et al.
`Ex. 1015 U.S. Provisional Patent Application No. 61/332,954
`International Standard ISO 3530-1, 1st ed. (1992)
`Ex. 1016
`Ex. 1017
`International Standard ISO 3630-1, 2nd ed. (2008)
`Salwa E. Khier et al., Bending properties of superelastic and
`Ex. 1018
`nonsuperelastic nickel-titanium orthodontic wires, 99 AM. J.
`ORTHODONTICS & DENTOFACIAL ORTHOPEDICS 310 (1991)
`(“Khier”)
`Ex. 1019 Gregoire Kuhn & Laurence Jordan, Fatigue and Mechanical
`Properties of Nickel-Titanium Endodontics Instruments, 28 J.
`Endodontics 716 (2002) (“Kuhn”)
`Ex. 1020 U.S. Patent No. 5,628,674 to Heath et al.
`
`ix
`
`

`
`Ex. 1021
`
`Ex. 1025
`
`Ex. 1026
`
`Ex. 1027
`
`Ex. 1028
`
`Edgar Schäfer et al., Bending properties of rotary nickel-titanium
`instruments, 96 ORAL SURGERY ORAL MEDICINE ORAL
`PATHOLOGY 757 (2003)
`Ex. 1022 U.S. Patent App. Pub. No. 2002/0137008 A1, McSpadden et al.
`(“McSpadden”)
`Ex. 1023 U.S. Patent No. 7,713,815 B2 to Matsutani et al. (“Matsutani”)
`S. Miyazaki et al., Characteristics of Deformation and
`Ex. 1024
`Transformation Pseudoelasticity in Ti-Ti Alloys, 43 J. PHYSIQUE
`COLLOQUES C4-255 (1982)
`Franklin S. Weine, ENDODONTIC THERAPY, 6th Ed., 2004,
`Chapter 5 (“Weine”)
`Japanese Unexamined Patent Application Publication No. 2006-
`149675, Matsutani et al.
`English translation of Japanese Unexamined Patent Application
`Publication No. 2006-149675, Matsutani et al.
`Transcript of May 20, 2015 teleconference before the United States
`Patent and Trademark Office Patent Trial and Appeal Board
`Ex. 1029 Gold Standard Instruments LLC’s Website
`Ex. 1030
`Prosecution file history for U.S. Patent No. 8,876,991
`
`Patent Owner’s Previous Exhibits
`
`Ex. 2001
`
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Preliminary
`Injunction Hearing Transcript, Volume I, dated Nov. 25, 2014 (E.D.
`Tenn.), pp. 1, 2, 11, 12, 15, 19, 20, 27-30, 32-59, 65, 66, 76, 141,
`152, 163-65, 168, 170, 176, 240, 243, 249, 261, 262, 279, and 301
`(index).
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Preliminary
`Injunction Hearing Transcript, Volume I, dated Nov. 25, 2014 (E.D.
`Tenn.), pp. 1, 2, 11, 12, 15, 19, 20, 27-30, 32-59, 65, 66, 76-78, 141,
`152, 163-65, 168, 170, 176, 240, 243, 249, 261, 262, 279, and 301
`(index).
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Preliminary
`Injunction Hearing Transcript, Volume II, dated Nov. 26, 2014 (E.D.
`Tenn.), pp. 1, 2, 10, 51, 99-105, 129, 131, 159, 172-74, 180-81, and
`197 (index).
`
`Ex. 2001
`(Substitute)
`
`Ex. 2002
`
`x
`
`

`
`Ex. 2002
`(Substitute)
`
`Ex. 2003
`
`Ex. 2004
`
`Ex. 2005
`
`Ex. 2006
`
`Ex. 2007
`
`Ex. 2008
`
`Ex. 2009
`
`Ex. 2010
`
`Ex. 2011
`
`Ex. 2012
`
`Ex. 2013
`
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Preliminary
`Injunction Hearing Transcript, Volume II, dated Nov. 26, 2014 (E.D.
`Tenn.), pp. 1, 2, 10, 37-51, 55-57, 99-105, 129, 131, 159, 172-74,
`180-81, and 197 (index).
`PCT application publication WO 2005/122942 (filed June 7, 2005),
`Neill H. Luebke.
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Deposition
`Transcript of Neill H. Luebke, dated Oct. 8, 2014 (E.D. Tenn.), pp. 1
`and 108-113.
`U.S. Patent No. 4,850,867 (filed Feb. 5, 1988), Figure 2 and
`column 3.
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Declaration of
`John Voskuil, filed July 9, 2014 (E.D. Tenn.).
`Prosecution history of Edge Endo, LLC’s U.S. Trademark Reg. No.
`4,638,335 (as of May 5, 2015), pages showing attorney of record and
`owner.
`Guidance Endodontics, LLC v. Dentsply Int’l, Inc., No. 8-1011,
`Verified Complaint and Demand for Jury Trial, filed Nov. 21, 2008
`(D. N.M.), pp. 1-4 and 39.
`Edge Endo, LLC’s Certificate of Organization from the New Mexico
`Office of the Secretary of State, Business Services Division, printed
`from
`<https://portal.sos.state.nm.us/Corps/(S(i5r3f50hyk3b4l3jrf0vmebq))
`/Corplookup/Details.aspx?Nmscc=4553560> (Mar. 26, 2014).
`US Endodontics, LLC’s Certificate of Organization from the New
`Mexico Office of the Secretary of State, Business Services Division,
`printed from
`<https://portal.sos.state.nm.us/Corps/(S(i5r3f50hyk3b4l3jrf0vmebq))
`/Corplookup/Details.aspx?Nmscc=4368676> (Mar. 27, 2014).
`Sharon Bettes-Groves’ LinkedIn profile (Feb. 9, 2015), printed from
`<https://www.linkedin.com/pub/sharon-bettes-groves/80/aa9/ab7>.
`Edge Endo, LLC’s product information for the EdgeFile (Oct. 30,
`2014), printed from <http://edgeendo.com/products/edgefile/>.
`Prosecution history of Guidance Endodontic, LLC’s U.S. Trademark
`Reg. No. 3,496,991 (as of May 5, 2015), pages showing attorney of
`record.
`
`xi
`
`

`
`Ex. 2014
`
`Ex. 2015
`
`Ex. 2016
`
`Ex. 2017
`
`Ex. 2018
`
`Ex. 2019
`
`Ex. 2020
`
`Ex. 2021
`
`Ex. 2022
`
`
`
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, US Endodontics,
`LLC’s Counter-Designations to Plaintiffs’ Designations of Bobby
`Bennett Deposition Testimony and Redacted Public Version of the
`Designated Transcript, dated Dec. 12, 2014 (E.D. Tenn.), pp. 1, 29-
`32, 36, 58-61, 65, 67, 68, 71, 79, 80, 93, 98, 99, 145, 149, 150, 187,
`195, 196, 200, 221-224, and 229.
`Guidance Endodontics, LLC’s FDA Establishment Registration and
`Device Listing for the Edge File product (Apr. 2, 2015), printed from
`<http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=
`88956&lpcd=EKS>.
`US Endodontics, LLC’s FDA Establishment Registration and Device
`Listing for the Edge File product (Apr. 2, 2015), printed from
`<http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=
`383462&lpcd=EKS>.
`Edge Endo, LLC’s testing study for the EdgeFile (Apr. 14, 2014),
`printed from <http://edgeendo.com/resources/testing/>.
`Edge Endo, LLC’s Edge Store page for the EdgeFile (May 4, 2015),
`printed from <https://store.edgeendo.com/edgefile-c21.aspx>.
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Plaintiff’s Motion
`for a Preliminary Injunction, filed July 9, 2014 (E.D. Tenn.).
`Powerpoint slides presented by Petitioner’s Expert Dr. Jeffrey Stec in
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, (E.D. Tenn.).
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, excerpts from
`Transcript of Hearing on Motion for Preliminary Injunction, held
`November 25, 2014 (E.D. Tenn.).
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, excerpts from
`Transcript of Hearing on Motion for Preliminary Injunction, held
`November 26, 2014 (E.D. Tenn.).
`
`New Exhibits
`
`Ex. 2001
`(Second
`
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Preliminary
`
`xii
`
`

`
`Substitute)
`
`Ex. 2002
`(Second
`Substitute)
`
`Ex. 2023
`
`Ex. 2024
`
`Ex. 2025
`
`Ex. 2026
`Ex. 2027
`Ex. 2028
`Ex. 2029
`
`Ex. 2030
`
`Ex. 2031
`
`Ex. 2032
`
`Ex. 2033
`Ex. 2034
`
`Ex. 2035
`Ex. 2036
`
`Ex. 2037
`
`Injunction Hearing Transcript, Volume I, dated Nov. 25, 2014 (E.D.
`Tenn.) (Complete transcript and index).
`Dentsply Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196, Preliminary
`Injunction Hearing Transcript, Volume II, dated Nov. 26, 2014 (E.D.
`Tenn.) (Complete transcript and index).
`Patent Owner Gold Standard Instruments, LLC’s Notice of Cross-
`Examination of A. Jon Goldberg, Ph.D., dated October 5, 2015.
`Kuhn et al., “Influence of Structure on Nickel-Titanium Endodontic
`Instruments Failure,” Journal of Endodontics, 27(8), 516-20 (Aug.
`2001).
`Deposition Transcript of A. Jon Goldberg, Ph.D., dated September
`30, 2014, taken in Dentsply Int’l Inc. and Tulsa Dental Prods. LLC
`d/b/a/ Tulsa Dental Specialties v. US Endodontics, LLC, No. 2:14-
`196 (E.D. Tenn.).
`Declaration of Robert Sinclair, Ph.D.
`Declaration of Neill H. Luebke, D.D.S., M.S.
`Declaration of Ronald R. Lemon, D.M.D.
`Camps et al., Torsional and Stiffness Properties of Nickel-titanium K
`Files, 28 Int’l Endodontic J., 249.
`Declaration of Nolan Knight, with Exhibit A, Bending Test Report
`on EdgeFiles.
`Declaration of Noah Menard, with Exhibit A, DSC Test Report on
`EdgeFiles.
`ASTM International, F2004-05 (2010), Standard Test Method for
`Transformation Temperature of Nickel-Titanium Alloys by Thermal
`Analysis.
`U.S. Patent No. 5,843,244 (filed Jun. 13, 1966).
`US Endodontics, LLC v. Gold Standard Instruments, LLC, IPR2015-
`00632, Deposition Transcript for the Deposition of Dr. A. Jon
`Goldberg (Oct. 20, 2015).
`Guhring, Inc., Guhring Coating Services 2003.
`Testarelli et al., “Bending Properties of a New Nickel-Titanium Alloy
`with a Lower Percent by Weight of Nickel,” Journal of Endodontics,
`37(9), 1293-95 (Sept. 2011).
`Deposition Transcript of Robert Sinclair, Ph.D., dated September 30,
`2014, taken in Dentsply Int’l Inc. and Tulsa Dental Prods. LLC
`d/b/a/ Tulsa Dental Specialties v. US Endodontics, LLC, No. 2:14-
`196 (E.D. Tenn.).
`
`xiii
`
`

`
`Ex. 2038
`
`Ex. 2039
`
`Ex. 2040
`
`Ex. 2041
`
`Ex. 2042
`Ex. 2043
`
`
`
`Expert Report of Robert Sinclair, dated Sept. 12, 2014, in Dentsply
`Int’l Inc. and Tulsa Dental Prods. LLC d/b/a/ Tulsa Dental
`Specialties v. US Endodontics, LLC, No. 2:14-196 (E.D. Tenn.).
`Secrecy Agreement between Dr. Neill H. Luebke and
`Coltene/Whaledent, dated Sept. 16, 2008.
`Email communication from Patrick Huddie to Dr. Neill H. Luebke,
`dated May 20, 2010.
`Product brochure for Coltene’s HyFlexCM file (Nov. 4, 2015),
`downloaded from: http://www.hyflexcm.com/downloads.html.
`EXHIBIT NUMBER NOT USED.
`Product information on Vortex Blue (June 11, 2014), printed from:
`<http://www.tulsadentalspecialties.com/defaut/endodontics_brands/
`Vortex_Blue.aspx> (The text cited in Plaintiff’s brief has been
`highlighted in yellow for ease of reference).
`
`xiv
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`

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`The Board instituted inter partes review of the ’773 patent on four grounds:
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`(A) claims 1, 2 and 9-12 under § 102(b) based on Kuhn; (B) claims 8, 13, 15 and
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`17 under § 103(a) based on Kuhn and the 1992 ISO; (C) claims 1-17 under
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`§ 103(a) based on Kuhn, the 1992 ISO, McSpadden, and Pelton; and (D) claims 1-
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`17 under § 103(a) based on Matsutani, Pelton, and the 1992 ISO. Paper 29, 32.
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`Pursuant to Rule 42.120(a), Gold Standard Instruments, LLC (“GSI”) submits this
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`Patent Owner Response.
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`I.
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`INTRODUCTION
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`The ʼ773 patent is directed to a method of heat treating a superelastic NiTi
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`endodontic instrument (e.g., a file), whereby the entire shank of the file is heat-
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`treated to minimize its superelastic properties and make the file more flexible and
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`permanently deformable. Ex. 1001. Dr. Neill Luebke, the inventor of the ’773
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`patent and a practicing endodontist, was the first person to heat-treat a superelastic
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`NiTi file for this purpose. The conventional wisdom at the time of Dr. Luebke’s
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`invention was that NiTi’s superelasticity was advantageous and that softer files
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`such as those that result from Dr. Luebke’s innovative process were undesirable
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`and in fact unsuitable. Ex. 2027, ¶¶37-38; Ex. 2028, ¶¶22-26, 32, 46-47.
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`The claims of the ’773 patent expressly require that heat-treatment be
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`applied to the entire shank, at a temperature of 400°C degrees up to the melting
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`point (claim 1) or at 475°C to 525°C (claim 13). The claims also require that the
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`1
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`heat-treatment result in a file that permanently deforms at least 10 degrees when
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`tested in accordance with the bend test for root canal instruments set forth in the
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`ISO 3630-1, Dentistry—Root Canal Instruments—Part 1: General Requirements
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`(“ISO Standard 3630-1”).1 The invention exhibits two major improvements over
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`prior art files: (1) it fractures less often during use; and (2) it better negotiates the
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`root canal without damaging the tooth. Ex. 1001 at 9:19-30; Ex. 2028, ¶¶34-45.
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`None of the prior art upon which Petitioner relies either anticipates or
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`renders obvious the claimed invention. Indeed, none of the references, either alone
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`or in combination, teach or suggest heat-treating a machined NiTi file for the
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`purpose of reducing the superelasticity to make a softer, more deformable file—
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`much less the particular level of permanent deformation required by the claims.
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`Petitioner makes three errors in arguing to the contrary. First, it redefines
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`permanent deformation in a manner directly contrary to the claims and disclosure
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`of the ʼ773 patent—and as that term has been construed by the Board—in order to
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`argue that that limitation is present in (or obvious in view of) the prior art. Second,
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`it selectively reads the prior art references, handpicking out of context statements
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`while ignoring teachings of each reference that when taken as a whole teach away
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`from the claimed invention. Third, Petitioner relies on hindsight to combine the
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`1 ISO (the International Organization for Standardization) is a worldwide
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`federation of national standards bodies. Ex. 1017 at iv.
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`2
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`references because none of the references themselves suggest their combination.
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`Petitioner also relies on improper hindsight to argue that the permanent
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`deformation limitation is satisfied by the cited prior art, while ignoring the repeated
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`teachings away. As GSI will show below, when the claims are read to require the
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`permanent deformation limitation, as the Board has already determined is
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`appropriate, Petitioner has failed to establish that claims 1-17 are anticipated or
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`rendered obvious by the prior art. The patentability of the claimed invention is
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`confirmed by undisputed evidence regarding objective indicia of nonobviousness.
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`II. THE ’773 PATENT
`A. General Background of the ’773 Patent
`1. How Endodontic Files are Used
`Endodontics is the branch of dentistry concerned with disease of the soft
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`
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`inner tissue of the tooth, known as pulp, which is made up of nerves, blood, and
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`connective tissue. Ex. 1001, 1:31-35; Ex. 2027, ¶7; Ex. 2028, ¶¶9-11. During a
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`root canal (endodontic therapy), the diseased or decayed material is removed, then
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`the canal is shaped, filled with an inert material, and sealed in order to preserve the
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`tooth. Ex. 2027, ¶8; Ex. 2028, ¶12. To remove the pulp and shape the root canal, an
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`endodontist uses a small instrument known as an endodontic file. Ex. 2027, ¶9; Ex.
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`2028, ¶¶9,12-13, 15. The graphic below generally depicts an endodontic file of the
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`type described in the prior art.
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`3
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`.
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`Ex. 2027, ¶9.
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`Prior to the 1990s, endodontic files were generally hand-held (manually
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`operated) files made of stainless steel. Ex. 2027, ¶10; Ex. 2028, ¶15. One of the
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`challenges faced by endodontists is that a significant number of the root canals are
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`naturally curved, making it difficult for the endodontist to navigate a long, curved
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`canal with a straight endodontic file. Ex. 1001, 1:58–2:23; Ex. 2027, ¶¶11-12; Ex.
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`2028, ¶14. The forces exerted against the canal by the file can lead to mishaps
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`known as zipping, ledging, transportation (or perforation), and file separation
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`(fracture). Ex. 1001, 2:13-23; Ex. 2027, ¶¶13-16, 19-20; Ex. 2028, ¶¶15-21.
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`In the early 1990s, NiTi succeeded stainless steel as the material of choice
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`for endodontic files because of its balance of flexibility and strength as compared
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`to stainless steel. Ex. 2027, ¶17; Ex. 2028, ¶¶22-25. That is, NiTi was sufficiently
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`strong for use as an endodontic file, while being more flexible than stainless steel
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`but not to the point of feeling like a “wet noodle.” Ex. 2027, ¶17; Cf. Ex. 1025,
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`211. Endodontists also preferred NiTi’s superelastic behavior, which was viewed
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`as a benefit over prior stainless steel files. Ex. 2027, ¶17; Ex. 2028, ¶¶22, 24-25,
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`32. Superelasticity allows files to “spring back” after being bent in a root canal. Ex.
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`2027, ¶17; Ex. 2028, ¶26. The availability of superelastic NiTi also led to the
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`4
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`development of rotary endodontic files (i.e., electric drills known as dental hand
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`pieces). Ex. 2027, ¶18; Ex. 2028, ¶¶22, 25.
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`Although NiTi files, when introduced in the early 1990s, were viewed as an
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`improvement over the earlier stainless steel hand files, endodontists recognized at
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`the time that the superelastic NiTi rotary files had a tendency to fracture during use
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`due to the lateral stresses placed on the file (particularly when used in a rotary hand
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`piece) in a tooth’s curved root canal. Ex. 2027, ¶19; Ex. 2028, ¶26. When a file
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`breaks, a broken file piece often remains in the patient’s tooth, and a dentist or
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`endodontist must then try to remove it. Ex. 2027, ¶¶20-21; Ex. 2028, ¶20. While
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`superelastic NiTi reduced the frequency of ledging, perforation, and other
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`problems encountered with stainless steel files, those problems still occurred with
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`the superelastic NiTi files. Ex. 2027, ¶¶17, 19, 23; Ex. 2028, ¶¶26, 42. That is
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`because superelastic NiTi files have shape memory, meaning they spring back to
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`their original shape (or close thereto) when bent. Id.
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`For a period of more than 10 years, the industry tried to fix this problem in
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`many ways—without success. Ex. 2027, ¶22; Ex. 2028, ¶¶27-32. For example, the
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`dental industry increased the size and taper of the file, but this failed to solve the
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`problem. Ex. 2027, ¶22; Ex. 2028, ¶30. Larger files also created another problem
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`because they removed more tooth structure, compromising the tooth. Id. The ’773
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`patent is directed to a process for making an improved, heat-treated NiTi file that
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`5
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`better navigates the root canal and solved the fracture problem seen with
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`superelastic NiTi files. Ex. 1001, 2:56-3:2.
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`Dr. Luebke’s Invention
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`2.
`Starting in 1995, Dr. Luebke—then a practicing endodontist—recognized
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`these problems and spent substantial time and personal funds researching how to
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`improve NiTi files. Ex. 2027, ¶25. Dr. Luebke first considered making a sharper
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`file, evaluating both a diamond coating and a titanium-nitride coating. Id., ¶¶26-27.
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`Then Dr. Luebke heat-treated files without those coatings and had a
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`“eureka” moment. Id., ¶¶28-31. Dr. Luebke found that heat-treatment lessened the
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`NiTi’s superelasticity, making the files softer and more easily deformable. Id., ¶29.
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`The heat-treated NiTi files stayed bent, instead of springing back like conventional,
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`non-heat-treated superelastic NiTi files. Id. Dr. Luebke’s heat-treated NiTi files
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`exhibited greater than 10 degrees of permanent deformation when tested in
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`accordance with the ISO Standard 3630-1 bend test, whereas non-heat-treated
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`superelastic files demonstrated only a de minimis amount of permanent
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`deformation in this test. Id., ¶32; Ex. 1001, Fig. 6, 8:34-59.
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`Unlike the prior art NiTi files, Dr. Luebke’s invention resulted in a softer,
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`more deformable file, which allowed it to navigate the root canal’s curvature
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`without damaging the tooth. Ex. 2027, ¶¶29-32; Ex. 2028, ¶¶34-37, 43-45. This
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`reduced the occurrence of file fracture, zipping, ledging, and perforation. Id.
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`6
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`After he filed his PCT application in 2005, Dr. Luebke attempted to market
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`his invention to endodontic companies. Ex. 2027, ¶¶37, 39-44. For years, Dr.
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`Luebke’s invention was met with skepticism by others in the industry. Id., ¶¶37-38.
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`But, in 2014, Dr. Luebke’s company, GSI, eventually licensed the ’773 and other
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`patents to Dentsply International Inc. and its subsidiary, Tulsa Dental Products
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`LLC (collectively “Dentsply”). Id., ¶44. Dentsply manufactures and sells a post-
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`machined heat-treated NiTi file called the Vortex Blue® that is made by the
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`patented method. Ex. 2006, ¶9; Ex. 2027, ¶45. The Vortex Blue® has been a
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`commercially successful product since it was introduced. Ex. 2027, ¶45.
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`Once files made using Dr. Luebke’s post-heat treatment process were
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`introduced, the industry recognized the benefits, and many practitioners switched
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`over to these softer files. Ex. 2028, ¶¶34-45. Several other companies hav